Drug injection of recombinant human erythropoietin

A technology for erythropoietin and injections, which is applied in the field of drug injections of recombinant human erythropoietin, can solve problems such as complex production processes, and achieve the effects of simple formula, reduced drug auxiliary components, and reduced production costs

Active Publication Date: 2009-06-24
科兴生物制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to stabilize the recombinant human erythropoietin solution, the existing invention uses a variety of excipients, the production process is complicated, and the quality of the drug caused by the quality of the excipients has attracted more and more attention.

Method used

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  • Drug injection of recombinant human erythropoietin
  • Drug injection of recombinant human erythropoietin
  • Drug injection of recombinant human erythropoietin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Prepare 3000 recombinant human erythropoietin injections of 3000IU / ml /

[0034] 1. Formula composition:

[0035] Recombinant Human Erythropoietin 3000IU / ml

[0036] Polysorbate 80 0.03mg / ml

[0037] Sodium dihydrogen phosphate dihydrate 2.22mg / ml

[0038] Disodium hydrogen phosphate dodecahydrate 6.45mg / ml

[0039] Sodium chloride 8.7mg / ml

[0040] Water for injection up to 3000ml

[0041] 2. Preparation:

[0042] Measure the medicinal amount of recombinant human erythropoietin stock solution, 90mg polysorbate 80, add 18mM sodium dihydrogen phosphate / disodium hydrogen phosphate buffer solution, containing 26.1g sodium chloride to 3000ml, shake well.

[0043] 3. Packing;

[0044] Sterile filter the prepared solution into sterile containers. Then it is divided into medical glass containers, 1 ml is added to each bottle, and filled to make 3000 IU / ml recombinant human erythropoietin injection.

Embodiment 2

[0046] Preparation of 3000 recombinant human erythropoietin injections of 6000IU / ml /

[0047] 1. Formula composition:

[0048] Recombinant Human Erythropoietin 6000IU / ml

[0049] Polysorbate 80 0.03mg / ml

[0050] Sodium dihydrogen phosphate monohydrate 1.68mg / ml

[0051] Disodium hydrogen phosphate 2.56mg / ml

[0052] Sodium chloride 8.7mg / ml

[0053] Water for injection up to 3000ml

[0054] 2. Preparation:

[0055] Measure the medicinal amount of recombinant human erythropoietin stock solution, 90mg polysorbate 80, add 18mM sodium dihydrogen phosphate / disodium hydrogen phosphate buffer solution, containing 26.1g sodium chloride to 3000ml, shake well.

[0056] 3. Packing;

[0057] Sterile filter the prepared solution into sterile containers. Then it is divided into medical glass containers, 1 ml is added to each bottle, and filled to make 6000 IU / ml recombinant human erythropoietin injection.

[0058]The injection of the present invention exhibits pharmacokinetic prop...

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Abstract

The present invention provides a medicine injection of recombinant human erythropoietin. It contains no human serum albumin, and uses a certain quantity of the derivative of polyoxyethylene sorbitan fatty acid as stabilizing agent. It can be more safely used for curing or preventing diseases applicable to erythropoietin.

Description

technical field [0001] The invention relates to a pharmaceutical injection of recombinant human erythropoietin without human serum albumin and its application. It uses a certain amount of derivatives of polyoxyethylene sorbitan fatty acid ester as a stabilizer, does not contain human serum albumin, has long-term storage stability, and has no risk of virus pollution and human serum albumin allergy. field of pharmaceutical preparations. technical background [0002] Recombinant human erythropoietin (Erythropoietin, erythropoietin) is a glycoprotein with a molecular weight of about 30-39KD. It can be divided into a and b according to the difference in its glycoform structure. Its physiological function is to stimulate the formation of hemoglobin or red blood cells in the bone marrow, which is mainly produced by the kidney and enters the bone marrow through circulating blood. Recombinant human erythropoietin has the same structure and physiological function as the natural eryth...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/18A61K47/34A61K47/24A61K47/12A61P7/06A61K47/26
Inventor 于萍李庆河苏焕然赵先亮郗遵波
Owner 科兴生物制药股份有限公司
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